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USP DI Vol. II - DANAPAROID (Systemic)

DANAPAROID (Systemic)


Some commonly used brand names are:

In the U.S.?

  • Orgaran

Category

  • Antithrombotic

Description

Danaparoid (da-NAP-a-roid)is used to prevent deep venous thrombosis, a condition in which harmful bloodclots form in the blood vessels of the legs. These blood clots can travelto the lungs and can become lodged in the blood vessels of the lungs, causinga condition called pulmonary embolism. Danaparoid is used for several daysafter hip replacement surgery, while you are unable to walk. It is duringthis time that blood clots are most likely to form. Danaparoid also may beused for other conditions as determined by your doctor.

Danaparoid is available only with your doctor's prescription, in the followingdosage form:

    Parenteral
  • Injection (U.S.)


Before Using This Medicine

In deciding to use a medicine,the risks of using the medicine must be weighed against the good it will do.This is a decision you and your doctor will make. For danaparoid, the followingshould be considered:

Allergies?Tell your doctor if you have ever had any unusual orallergic reaction to danaparoid or heparin. Also tell your health care professionalif you are allergic to any other substances, such as foods, especially porkor pork products, preservatives, or dyes.

Pregnancy?Danaparoid has not been studied in pregnant women.However, it has not been found to cause birth defects in animals.

Breast-feeding?It is not known whether this medicine passes intobreast milk. Although most medicines pass into breast milk in small amounts,many of them may be used safely while breast-feeding. Mothers who are usingthis medicine and who wish to breast-feed should discuss this with their doctor.

Children?Studies on this medicine have been done only in adultpatients, and there is no specific information comparing use of danaparoidin children with use in other age groups.

Older adults?Many medicines have not been studied specificallyin older people. Therefore, it may not be known whether they work exactlythe same way they do in younger adults or if they cause different side effectsor problems in older people. There is no specific information comparing useof danaparoid in the elderly with use in other age groups.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases two different medicines may be used togethereven if an interaction might occur. In these cases, your doctor may want tochange the dose, or other precautions may be necessary. Tell your health careprofessional if you are using any other prescription or nonprescription (over-the-counter[OTC]) medicine.

Other medical problems?The presence of other medicalproblems may affect the use of danaparoid. Make sure you tell your doctorif you have any other medical problems, especially:

  • Bleeding problems or
  • Heart infection or
  • High blood pressure (hypertension) or
  • Kidney disease or
  • Stomach or intestinal ulcer (active) or
  • Stroke?The risk of bleeding may be increased

Also, tell your doctor if you have received danaparoid before and had areaction to it called thrombocytopenia (a low platelet count in the blood),or if new blood clots formed while you were receiving the medicine.

In addition, tell your doctor if you have recentlyhad medical surgery. This may increase the risk of serious bleedingwhen you are taking danaparoid.


Proper Use of This Medicine

If you areusing danaparoid at home, your health care professional will teach you howto inject yourself with the medicine. Be sure to followthe directions carefully. Check with your health care professional if youhave any problems using the medicine.

Put used syringes in a puncture-resistant, disposablecontainer, or dispose of them as directed by your health care professional.

Dosing?The dose of danaparoid may be different fordifferent patients. Follow your doctor's orders or thedirections on the label. The following information includes only theaverage doses of danaparoid. If your dose is different,do not change it unless your doctor tells you to do so.

  • For injection dosage form:
    • For prevention of deep venous thrombosis (leg clots) and pulmonaryembolism (lung clots):
      • Adults?750 anti-factor Xa units, injected under the skin, twotimes a day for up to fourteen days after surgery.
      • Children?Use and dose must be determined by your doctor.

Missed dose?If you miss a dose of this medicine, use it assoon as possible. However, if it is almost time for your next dose, skip themissed dose and go back to your regular dosing schedule. Do not double doses.

Storage?To store this medicine:

  • Keep out of the reach of children.
  • Store away from heat and direct light.
  • Keep the medicine from freezing. Do not refrigerate.
  • Do not keep outdated medicine or medicine no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Tell all your medical doctors and dentists that you are usingthis medicine.

Check with your doctor immediately if you notice anyof the following side effects:

  • Bruising or bleeding, especially bleeding that is hard to stop. Bleedinginside the body sometimes appears as bloody or black, tarry stools, or faintness.
  • Back pain; burning, pricking, tickling, or tingling sensation; legweakness; numbness; paralysis; or problems with bowel or bladder function.


Side Effects of This Medicine

Along with its needed effects, a medicine maycause some unwanted effects. Although not all of these side effects may occur,if they do occur they may need medical attention.

    Stop using this medicineand check with your doctor immediately if any of the following sideeffects occur:

      Less common

        Bleeding gums; coughing up blood; difficulty in breathing or swallowing; dizziness; headache; increasedmenstrual flow or vaginal bleeding; nosebleeds; paralysis; prolonged bleeding from cuts; red or dark brown urine; red or black, tarry stools; shortness of breath; unexplained pain, swelling, or discomfort, especially in thechest, abdomen, joints, or muscles; unusual bruising; vomiting of blood or coffee ground-like material;weakness

      Rare

        Back pain; burning, pricking, tickling,or tingling sensation; leg weakness; numbness; problems with bowel or bladderfunction

      Also,check with your doctor as soon as possible if any of the following side effectsoccur:

        Less common

          Fever

        Rare

          Skin rash

Other side effects may occurthat usually do not need medical attention. These side effects may go awayduring treatment as your body adjusts to the medicine. However, check withyour doctor if any of the following side effects continue or are bothersome:

    More common

      Pain at injection site

    Less common

      Constipation; nausea

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.


Developed: 07/10/98